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Agreements

Date: 2012-06-13

Type of information: Licensing agreement

Compound: Sitavig® (Acyclovir Lauriad™)

Company: BioAlliance Pharma (France) Abic Marketing Limited,a group subsidiary of Teva Pharmaceutical (Israel)

Therapeutic area: Infectious diseases

Type agreement:

licensing

Action mechanism:

Disease: recurrent labial herpes in immunocompetent patients

Details:

BioAlliance Pharma, a company dedicated to oncology orphan products and specialty products has announced the signature of an exclusive license agreement for Sitavig® (Acyclovir Lauriad™) with Abic Marketing Limited, a group subsidiary of Teva Pharmaceutical Industries for commercialization rights in Israel.
BioAlliance Pharma has conceived and developed Sitavig® for the treatment of recurrent labial herpes in immunocompetent patients presenting more than 4 episodes a year. Sitavig® is based on the innovative mucoadhesive buccal technology Lauriad™, delivering very high concentrations of acyclovir at the site of herpes infection. The phase III trial (775 patients) has shown a strong efficacy and safety profile, basis for the registration submission. The trial showed a significant reduction in the occurrence of vesicular lesions (p=0.043), in the time to healing of vesicular lesions (p=0.015), in the herpes episode duration (p=0.0038) and in theseverity of symptoms(p=0.008). Moreover, a 9-month follow-up showed that Sitavig® had an effect on the long term, delaying the time to occurrence of the following herpes episode (p=0.04).

Financial terms:

Financial terms of this license agreement are not publicly disclosed. This agreement includes upfront and milestone payments as well as royalties on sales in Israel, to be paid to BioAlliance Pharma by Teva.

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